ERCP With and Without EUS Guided HGS for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction

NCT06613945 | Recruiting

• 1 other identifier: MD.24.08.881
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective randomized clinical trial to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced malignant hilar biliary obstruction. The primary outcome will be technical success, clinical success, procedural duration, and re-interventions. Secondary outcomes will be the rate of adverse events. patients will be followed up at 1 and 3 month intervals

Conditions

Malignant Hilar Stricture

Keywords

Malignant Hilar Biliary Obstruction; Endoscopic Retrograde Cholangiopancreatography; Endoscopic Ultrasound Guided Hepaticogastrostomy

Outcome Measures

Primary Outcomes (4)

• Technical success

  considered after stent placement (expanded and patent) with good bile flow and drainage

  during the procedure

• Procedural duration

  defined as time from biliary cannulation to stent placement by ERCP, and time from needle puncture of the dilated bile duct to stent placement by EUS

  at the end of the procedure

• Clinical success

  considered at 2 weeks by a 50% decrease in total bilirubin levels from baseline and at 4 weeks if total bilirubin is less than 3mg/dL.

  3 month

• Re-interventions

  need for re-intervention to secure biliary drainage

  3 month

Secondary Outcomes (1)

• Adverse events

  3 month

Study Arms (2)

Combined EUS-HGS and ERCP biliary drainage

ACTIVE COMPARATOR

unilateral metallic stent will be inserted on right side through ERCP and a hepaticogastrostomy transmural stent will be inserted on left side by EUS to secure biliary drainage

Procedure: Combined ERCP and EUS-HGS biliary drainage

ERCP biliary drainage

ACTIVE COMPARATOR

bilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage

Procedure: ERCP biliary drainage

Interventions

ERCP biliary drainage PROCEDURE

bilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage

ERCP biliary drainage

Combined ERCP and EUS-HGS biliary drainage PROCEDURE

unilateral metallic stent will be inserted on right side by ERCP and a hepaticogastrostomy transmural stent will be inserted on left side by EUS to secure biliary drainage.

Combined EUS-HGS and ERCP biliary drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of inoperable malignant hilar biliary obstruction on magnetic resonance cholangiography, computed tomography and/or direct cholangiography bismuth type III \& IV only.
• Histologically confirmed malignant hilar biliary obstruction.
• Elevated serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL).
• Absence of duodenal narrowing/obstruction.
• Accept sharing in the study

You may not qualify if:

• Pregnancy.
• Distal biliary obstruction as the main lesion.
• Benign biliary stenosis.
• Malignant hilar biliary obstruction bismuth type I and II.
• Presence of duodenal obstruction.
• Surgically altered anatomy or inability to access the major duodenal papilla.
• Patients underwent previous intervention for biliary drainage.
• Previously failed biliary cannulation at ERCP.
• Large volume ascites.
• Patients unfit for anesthesia.
• Patients having uncorrectable coagulopathy or thrombocytopenia.
• History of allergy to radiocontrast agents.
• Refuse sharing in the study.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura univeristy

Al Mansurah, Dakahlia Governorate, 35511, Egypt

RECRUITING

Study Officials

• Mennatallah E saad, asslecturer

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mennatallah E Saad, Asslecturer

CONTACT

0502200590; mennaehab@mans.edu.eg

Ahmed Y Altonbary, Assprofessor

CONTACT

0502200590; a.tonbary@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: September 1, 2024
• Primary Completion: October 30, 2025
• Study Completion (Estimated): October 30, 2026
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)